Notice Number: NOT-NS-12-017
Update: The following update relating to this announcement has been issued:
- March 27, 2014 - See Notice NOT-NS-14-022. Notice of Modification of the Data Sharing Policy for the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System.
- March 21, 2013 - See Notice NOT-NS-13-018. Notice of Modification of the Data Sharing Policy for the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System.
Key Dates
Release Date: June 4, 2012
Response Date: June 30, 2012
NOT-NS-12-016
Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
Center for Information Technology (CIT)
Purpose
As stated in the recent Notice NOT-NS-12-016, the National Institutes of Health (NIH), in collaboration with the Department of Defense (DoD), is developing the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System to further accelerate the pace of discovery and advance research. The FITBIR Informatics System will provide the traumatic brain injury (TBI) research community with a common platform for exchanging data, protocols, and research-related information.
The goal of this RFI is to seek public comment on considerations in the development and implementation of the FITBIR Informatics System. Information obtained via this RFI will help to improve the design and policies of the FITBIR Informatics System to optimize its utility and productivity, and overall value to the scientific community and the public health.
Background
TBI is a major medical problem that lacks sensitive, predictive diagnostic tools and proven effective treatments. Developing effective diagnostics and treatments is challenging because of the heterogeneity of TBI, which spans all ages, evolves over time, and includes a wide variety of causes and injury severities. To address these challenges, the FITBIR Informatics System aims to provide high quality, highly granular and contemporary data that can be accessed and analyzed by scientific experts. The FITBIR Informatics System will enable central archiving of data from both prospective and retrospective studies, and thereby prevent the data sets from being lost to off-line, long-term storage in a multitude of distributed databases and institutions. A large, rich clinical data set that is stored in a secure, centralized database has the potential to address critical questions and fundamental needs in TBI diagnosis and treatment.
Functionality will include storage, query, retrieval, off-site backup, and optionally pre-processing, post-processing, and collaboration between approved researchers and federal agencies. Sharing of phenotypic, imaging, functional outcome, pathology, and genomic data from a central secure repository will greatly accelerate the ability for researchers to: (a) validate research results; (b) pool standardized information to improve statistical significance; (c) analyze data collected by others to explore new hypotheses as well as the variability in different treatment protocols, in an effort to improve TBI treatments for all; and (d) use sophisticated analysis tools to gain a better understanding of risk and mitigating factors in outcome after TBI.
Information Requested
This RFI invites input from potential FITBIR users as well as the broader biomedical research community and other interested parties on the following and other matters relating to the FITBIR Informatics System:
1. FITBIR Data Sharing Policies, including timelines for uploading and sharing data, and requirements for accessing data.
2. Strategies and incentives for promoting collaboration and use of the FITBIR Informatics System.
3. Issues regarding informed consent and re-consent for data sharing.
4. Research priorities for the FITBIR Informatics System.
5. Strategies and tools for increasing the availability of aggregate data and publications to the broad TBI community, e.g. patients and families, healthcare providers, policy makers, and other stakeholders.
Responses
Responses are due by June 30, 2012 and may be directed to:
FITBIR Operations Team
Email: [email protected]
Any personal identifiers (e.g., names, addresses, email addresses, etc.) will be removed when responses are compiled. Proprietary, classified, confidential, or sensitive information should not be included in your response. Replies to individual topics are optional, and anonymous responses are permitted. The information provided will be analyzed and may appear in various reports.
This Request for Information (RFI) is for planning purposes only and is not a solicitation for applications or an obligation on the part of the United States (U.S.) Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any comment submitted or for its use of that comment.Inquiries
For further information contact:
FITBIR Operations Team
Email: [email protected]
and Human Services (HHS)
